Reported Oct 9, 2019 · Terminated
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
Inter-Med LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inter-Med Llc · 2200 Northwestern Ave · Racine, WI · 53404-2500
Is this the product you have?
Vista Dental Products 3% Sodium Hypochlorite10- 3cc Pre-filled SyringesREF 502355
- Lot codes and dates
- UDI (01)10818207020410
- Lot/Work Order Numbers20182545 20182665 20190198 20190432 20190724 20190953 20191314
- Amount recalled
- 445 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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